Apricus Biosciences

Location: Sorrento Valley area of San Diego

Founded: 1994 (originally named NexMed)

Ownership: Public

Employees: 35

2010 revenue: $5 million

2010 loss: $29.5 million

Stock price: $4.88

What it does: Develops new formulations of government-approved drugs using its patented NexACT molecules, which loosen so-called tight junctions that bind skin cells to each other, creating space for drug molecules to move from the surface of the skin into the body.

Late-stage drug development programs

Vitaros: A topical erectile dysfunction drug that combines NexACT with alprostadil, which increases blood flow by expanding blood vessels. The medicine has been approved for sale in Canada and is awaiting a decision by European drug regulators.

Femprox: A topical female sexual arousal disorder therapy that combines NexACT with alprostadil. Apricus completed a Phase 2 trial of the drug on 98 patients in the United States and a Phase 3 trial on 400 women in China. The company is seeking partners to help conduct final trials and submit the therapy for regulatory review.

MycoVa: A topical toenail fungus drug that combines NexACT with terbinafine, an FDA-approved antifungal drug sold under the brand name Lamisil. The company is considering seeking regulatory review of MycoVa in North America and Europe after a new analysis of Phase 3 clinical trial data showed that it cured the infection in 20 percent of patients who didn’t also have athlete’s foot.

PrevOnco: Combines the acid-reflux drug lansoprazole with NexACT to treat advanced, inoperable liver cancer. The company is awaiting clearance from the Food and Drug Administration to begin a Phase 3 clinical trial of the drug on up to 218 patients for 12 months to 24 months. The agency gave the therapy orphan drug status, which will protect it from competition for seven years.

Apricus Biosciences learned that lesson when the San Diego company failed to get its experimental erectile dysfunction drug, Vitaros, onto the market ahead of Viagra, then nearly folded in 2009 when it ran short of money to continue late-stage development work.

Over the last year and a half, however, a management makeover and aggressive fundraising have fueled the publicly owned company’s comeback.

Apricus is poised to start selling Vitaros in Canada by November, and the topical drug could be on pharmacy shelves in Europe by late 2012 if regulators there endorse the therapy.

The commercial launch follows more than a decade of work on the drug and comes at a time when demand for male sexual medications such as Viagra and Cialis is growing at a healthy clip, especially among Baby Boomers who started turning 65 this year.

“Everywhere I go, there are tons of questions” about Vitaros, said Dr. Bassam Damaj, who became chairman and chief executive of Apricus in December 2009.

“It’s so attractive to people because they know it can sell unbelievably,” he said. “Revenue-wise, this is a blockbuster area.”

ED drugs sales reached nearly $2 billion in the United States in 2010 and $4.9 billion globally, according to IMS Health, a Norwalk, Conn.-based health research firm. That compares with 2006 sales of $1.4 billion in the United States and $3.4 billion worldwide.